BACKGROUNDA report about the HCV patients in Italy published by Cittadinanza Attivia and EpaC (two of the main HCV patients associations) shows that Italian Regions are significantly different in terms of structures and treatments for these kind of patients. The introduction of new therapies increased these differences in terms of access to new drugs. The number of centers that can administer these new therapies is not equally distributed among the Italian Regions.In Italy only 15% of HCV patients are eligible for new treatments and among these patients, only one out of four is actually treated. Only 353 Italian centers can effectively administer the new therapies, often with an insufficient medical staff in terms of number1. Moreover, these centers are not equally distributed in the Italian Regions: the table 1 shows the number of centers in the main Italian Regions (in two Regions equivalent in terms of population like Lombardy and Sicily, for example, there is a substancial difference in terms of centers per million inhabitants: 3,50 centers per million inhabitants in Lombardy and 2,20 centers per million inhabitants in Sicily).

COHORT OF HCV PATIENTS IN ITALY:SIZING AND TREATMENTS IN A SAMPLE

OF ITALIAN HEPATOLOGY CENTERSAuthors: Lanati EP1, Lidonnici D1, Gasbarrini A2, Ruggeri M3, Sacchini D3, Caporaso N4, Fagiuoli S5

1MA Provider, Milano, Italy, 2Policlinico Gemelli, Rome, Italy, 3Università Cattolica del Sacro Cuore, Rome, Italy,4Universita’ di Napoli Federico II, Napoli, Italy, 5Papa Giovanni XXIII Hospital, Bergamo, Italy

PGI47

1). EpaC (http://www.epac.it/notizie/default.asp?id=890&id_n=11526)2). AIFA Data

Table 1. Number of prescribing centers in the main Italian Regions

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OBjECTIVESThe aim of this study is to give an overview of the treatments available for the patients with Hepatitis C Virus (HCV) through the segmentation of HCV patients in Italy.

METHODSThe study was carried out in 9 hepatology centers, treating HCV patients in 9 Italian Regions. The structures selected constitute a representative sample of the Italian scenario, being Centers of Excellence in HCV management in northern, southern, and center of Italy (representing about 24% of the 2.0002 patients treated with first generation Triple Therapy in Italy). The centers examined treat about 9.122 patients, 786 of whom transplanted (Table 2). In 2013 they treated about 851 patients, 378 with double therapy and 473 with triple therapy.

Table 2. HCV Patients Classification

Not classified

F3-F4

Trasplanted

F2

F0-F1

Patients classification

HCV Patients 2013Puglia

131

85

261

95

136

Bari

Campania

4

5

14

2

-

Napoli

Lombardia

2.400

1.000

900

-

500

Milano

Piemonte

452

323

833

-

-

Torino

FVG

12

34

38

-

-

Udine

Sicilia

46

67

99

27

4

Palermo

Lazio

25

32

11

-

-

Roma

Liguria

376

270

450

-

133

Genova

Marche

405

314

378

33

13

Ancona

3.851

2.130

2.984

157

786

Total

Total patients 572 25 4.300 1.608 84 239 68 1.096 1.130 9.122

The patients’ distribution has been investigated in terms of fibrosis stage (F0 to F4), therapy type (Triple, or Double therapy) and treatment status (naive or experienced patients).Some centers, like the one in Napoli and Udine, provided only information about patients treated in 2013 and not about the total number of HCV patients treated in the center.

RESULTSData (collected from structures and Workshop of Pharmacoeconomics in Hepatology) show that HCV patients are more concentrated in the two fibrosis stage extremes: 43% in F0-F1 Range, 23% in F2, 32% in F3-F4 Range and 2% unclassified (Table 2 - Figure 1). In some Regions there were also patients not classified (e.g. in Puglia there were 95 patients out of 572 not classified).

Figure 1. Fibrosis Stage Range

The percentage of patients treated in 2013 is significantly variable among the Regions investigated: it goes from the 3% of the total number of HCV patients in the center in Milan to the 64% of patients treated in the center in Palermo.Data about drug administration (Table3 - Figure 2 a) demonstrate that, at national level, patients are equally distributed between therapy type (56% TT and 44% DT) and treatment status (49% naive and 51% experienced).

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On the contrary, at Regional level many differences were found in all of the three parameters examined. In the structure investigated in Campania, for example, 72% of patients receive TT and 76% are experienced, while in Lazio 72% of patients receive DT and 72% are naive. Furthermore, considering the fibrosis stage, the 46% of patients treated in a center operating in Bari is in the range F3-F4, whilst in the center in Milan the 56% of the HCV patients treated is in range F0-F1 (Table 3 - Figure 2 b).

Table 3. Drug administration and patients status

With TT

With DT

Naive patients

Patients treated 2013

Total Patients

Bari

708

47

27

20

20

Napoli

25

25

7

18

6

Milano

4.300

145

58

87

85

Torino

1.608

140

50

90

60

Udine

84

84

24

60

25

Palermo

243

154

70

84

91

Roma

68

36

26

10

26

Genova

36

81

25

56

36

Ancona

1.143

139

91

48

72

8.215

851

378

473

421

Total

Experienced patients 27 19 60 80 59 63 10 45 67 430

% Experienced patients

% Naive patients

% TT

% DT 57%

43%

43%

57%

28%

72%

24%

76%

40%

60%

59%

41%

36%

64%

43%

57%

29%

71%

30%

70%

45%

55%

59%

41%

72%

28%

72%

28%

31%

69%

44%

56%

65%

35%

52%

48%

44%

56%

49%

51%

Figure 2 a. Drug administration

Figure 2 b. Patients status

CONCLUSIONSThe study demonstrates that, concerning the treatment of HCV, there are significant differences among the hepatology centers, both in terms of patients’ health status and therapy pathways. Common guideline, at national level, about the therapies and patients management could help the Regions and the prescribing centers in dealing with this pathology and its problems.

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